Beschreibung
Requirements
- Quality Engineering/Design or Process Excellence/Lean experience is preferred. ASQ certifications are an asset
- Strong engineering skills with working knowledge of: Process validation/verification activities
- Knowledge of the QSR, Design Controls, and ISO quality requirements. A minimum of 1 years of related experience is required, preferably within a regulated environment (eg FDA regulated)
- Experience conducting Process/Design Failure Mode Effects and Analysis
- Mechanical product knowledge is preferred. Problem solving techniques including 8D, root cause analysis and cause and effect analysis
- Knowledge on Statistical techniques and methods
- Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerance (GD&T)
- Familiarity with inspection methods and techniques
- Ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required
- Engineering, Technical, or Scientific discipline is required. An advanced degree in a related field is an asset
- Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing)
- Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired
- Working knowledge of Microsoft office products (Word, Excel, Access, and Project)
- Excellent written and oral communication skills
- Experience in CAPA execution and management
Is it you who we're looking for? Great! Don't hesitate to sending us your updates CV.
We're looking forward to getting to know you.